Noninvasive neuromodulation technologies that affect neuronal activity can modulate and potentially alter behavior, cognitive states, perception, and motor output without requiring an invasive procedure. To date, the majority of transdermal non-invasive neuromodulatory devices apply electrical energy to a subject's skin using one or more electrodes that typically attach to the neurostimulator via a cord or cable, which can be long and awkward to wear, particularly in a non-clinical or non-research setting.
For example, transcranial and/or transdermal electric stimulation (hereinafter “TES”) using scalp electrodes has been used to affect brain function in humans in the form of transcranial alternating current stimulation (hereinafter “tACS”), transcranial direct current stimulation (hereinafter “tDCS”), cranial electrotherapy stimulation (hereinafter “CES”), and transcranial random noise stimulation (hereinafter “tRNS”). Systems and methods for TES have been disclosed (see for example, Capel U.S. Pat. No. 4,646,744; Haimovich et al. U.S. Pat. No. 5,540,736; Besio et al. U.S. Pat. No. 8,190,248; Hagedorn and Thompson U.S. Pat. No. 8,239,030; Bikson et al. U.S. Patent Application Publication No. 2011/0144716; and Lebedev et al. U.S. Patent Application Publication No. 2009/0177243). tDCS systems with numerous electrodes and a high level of configurability have been disclosed (see for example Bikson et al. U.S. Patent Application Publication Nos. 2012/0209346, 2012/0265261, and 2012/0245653).
TES has been used therapeutically in various clinical applications, including treatment of pain, depression, epilepsy, and tinnitus. Despite the research to date on TES neuromodulation, existing systems and methods for delivering TES are lacking. In particular, systems having electrodes that are effective, comfortable, and easy-to-use, e.g., easy to apply and remove, particularly in a non-clinical (e.g., home) setting, have been lacking.
Most electrical stimulation systems targeting the nervous system incorporate a tabletop or handheld hardware comprising a user interface, electrical control circuitry, a power supply (e.g. battery), wires leading to electrodes affixed to a user, and predetermined and/or preconfigured electrical stimulation protocols. Conventional systems are limited regarding the comfort, design, and use of electrodes to deliver TES waveforms. For example, they may use uncomfortable and inflexible electrodes, such that the electrodes do not conform to the body of the user, resulting in uneven impedance, increased irritation during stimulation, and reduced cognitive effects. Further, most prior art electrodes are not well suited to attach to a wearable neurostimulator so that the neurostimulator is held to the body by the electrode.
Although a handful of small, lightweight and presumably wearable neuromodulation devices have been described, none of these systems include electrodes (e.g., disposable electrodes) for applying energy to a patient's head or head and having a cantilevered body that securely attaches to a small and wearable lightweight neurostimulator. Thus, there is a need for lightweight, wearable neuromodulation systems, and in particular for electrodes that reliably connect to such neuromodulation devices and contact two or more widely separated regions of the wearer's body, including the head or head and neck.
Further, there is a need for neurostimulators that use a variety of electrode configurations adapted for particular uses. Specifically, there is a need for electrode apparatuses (systems and devices) that can be automatically detected and/or identified by the neurostimulator. It would also be beneficial to provide neurostimulators and electrode apparatuses for use with reusable neurostimulators that are capable of detecting use and detecting and/or indicating when the electrode should be replaced.
It would be beneficial to provide one or more electrode apparatuses that include a pH regulating consumptive layer that is flexible and can make reliable electrical contact with the user's skin. Finally, it would also be useful to provide electrode assemblies that are capable of making reliable and durable electrical contact with the user's skin while allowing somewhat more forgiving attachment and/or support of a typically rigid wearable neurotransmitter.
Described herein are apparatuses (e.g., devices and systems), and methods that may address at least the needs identified above.